Model Number UP210 |
Device Problems
Use of Device Problem (1670); Improper Flow or Infusion (2954)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 08/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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As a preliminary result, it can be concluded that the customer used a software that was not intended for the described treatment.The manufacturer is waiting for further information regarding the incident.Further investigations will be planned as soon as more details are available.
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Event Description
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As per a manufacturer incident report we received from the factory in (b)(6): it was reported that the customer used an arthroscopy setup endoscope setup for a hysteroscopy.Since the arthroscopy software is not intended for this type of treatment, the customer provoked an embolism.According to customer's information, the patient has recovered completely.
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Manufacturer Narrative
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According to the investigation results, the wrong license was used (arthroscopy instead of hysteroscopy), where the flush volume and pressures have different limits.The irrigation pressure limit of the hysteroscopy software is 100 mmhg due to safety reasons.For this case, the most probable root cause is that the embolism was caused by a too high pressure.The customer will be informed about the misuse.
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Manufacturer Narrative
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This supplement report is filed to correct both the date of incident and the date report was received.
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Search Alerts/Recalls
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